Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07096960

Implementation of the START Intervention in Brazil: a Controlled Feasibility Trial

Led by Hospital Alemão Oswaldo Cruz · Updated on 2025-07-31

90

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

Sponsors

H

Hospital Alemão Oswaldo Cruz

Lead Sponsor

U

University College, London

Collaborating Sponsor

AI-Summary

What this Trial Is About

This controlled trial aims to assess the feasibility of a culturally adapted Brazilian version of the START (STrAtegies for RelaTives) program, a structured coping strategy program designed for family caregivers of people living with dementia. The program will be delivered by trained community general health workers (CGHW) in 10 municipalities across Brazil. Outcomes will include measures of feasibility and acceptability, as well as caregiver burden, mental health, and quality of life, assessed at baseline and after 6 months.

CONDITIONS

Official Title

Implementation of the START Intervention in Brazil: a Controlled Feasibility Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Informal caregivers 18 years or older who are primary or one of the primary persons responsible for caring for a family member with dementia
  • Caregivers providing regular and sustained emotional or practical support weekly
  • Caregivers living in the same household or nearby with frequent face-to-face interaction with the person with dementia
  • Care recipient with Clinical Dementia Rating (CDR) score 1 or higher
  • Care recipient with at least one ICD-10 dementia diagnosis code documented in their medical record
Not Eligible

You will not qualify if you...

  • Caregivers who are illiterate
  • Caregivers providing only occasional or sporadic support (less than weekly or without regular responsibility)
  • Care recipients who are institutionalized (living in long-term care facilities)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Lucas Martins Teixeira

Vitória, Espírito Santo, Brazil

Actively Recruiting

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Research Team

L

Lucas Martins Teixeira

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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Implementation of the START Intervention in Brazil: a Controlled Feasibility Trial | DecenTrialz